System and method for anatomical pathology sample handling, storage, and analysis

ABSTRACT

A carrier strip having a plurality of areas for retaining anatomical pathology specimens may have a backing, a cover coupled to the backing along side regions located along opposite longitudinal edges of the carrier strip and along lateral intermediate regions positioned between each of the plurality of areas for retaining anatomical pathology specimens. The carrier strip may be configured to individually retain each of the anatomical pathology specimens in one of the plurality of areas for retaining anatomical pathology specimens between the backing and the cover. Diagnostic studies of anatomical pathology specimens may be facilitated by distributing a digital copy of an image of the specimen may be to a pathologist. A diagnosis may be received from the pathologist based on the digital image of the specimen.

CROSS REFERENCE TO RELATED APPLICATION

This application is a continuation of and claims the benefit of andpriority to U.S. Provisional Patent Application No. 61/307,876 filedFeb. 25, 2010, entitled SYSTEM AND METHOD FOR ANATOMICAL PATHOLOGYSAMPLE HANDLING, STORAGE, AND ANALYTICAL, which document is herebyincorporated by reference to the extent permitted by law.

BACKGROUND

The present invention relates to methods of preparing anatomicalpathology specimens for study. In particular, the invention relates tomethods of preparing histopathology specimens that are conducive toautomated processes and more efficient storage.

The preparation of histological specimens from surgically obtainedtissue generally includes fixation, dehydration, clearing, andinfiltration of the specimen. Chemical fixation is often applied toprevent degradation of the specimen and allow for later long termstorage. An alternative to chemical fixation is frozen section fixationin which a specimen is quickly frozen, sectioned and prepared so thatevaluation of the specimen can be done in quickly, at times while thepatient is still in surgery. The invention disclosed in the presentapplication is envisioned as being most compatible with chemicallyfixated specimens, but may be used with frozen section samples as well.

After fixation of the specimen has been done to preserve the specimen,it may be dehydrated, cleared, and infiltrated. Because specimens willoften be prepared in blocks of material and then sliced or sectioned forstudy, the specimens must be made sufficiently rigid to allow forsectioning. In this process, the specimen is dehydrated with applicationof a water miscible stripping agent such as ethanol. The ethanol is thencleared from the specimen by application of a hydrophobic clearing agentsuch as xylene. The specimen may then be infiltrated with a matrixmaterial, such as paraffin wax or epoxy resin, to provide a block inwhich the specimen is suspended. The block may then be sectioned by atechnician and the sections mounted for analysis by a pathologist.

Traditionally, prepared specimens are mounted to glass or quartzmicroscope slides for analysis. The slides are fragile and must betransported and stored accordingly. This requires slides to be packagedin cassettes that results in a large amount of wasted space.Accordingly, it is an object of the present invention to provide asystem for high density storage of prepared histology specimens. It is afurther object of the present invention to provide for an automatedsystem for cataloging stored samples and digital images thereof tofacilitate analysis of the specimens by a remotely located pathologist.It is yet another object of the present invention to provide a system ofpeer review of histological diagnoses provided by one or morepathologists.

SUMMARY

Some aspects of the invention relate to a carrier strip having aplurality of areas for retaining anatomical pathology specimens thecarrier strip having a backing, a cover coupled to the backing alongside regions located along opposite longitudinal edges of the carrierstrip and along lateral intermediate regions positioned between each ofthe plurality of areas for retaining anatomical pathology specimens. Thecarrier strip may be configured to individually retain each of theanatomical pathology specimens in one of the plurality of areas forretaining anatomical pathology specimens between the backing and thecover.

Other aspects of the present invention relate to method of handlinganatomical pathology specimens including placing a specimen on aspecimen carrier strip backing. The specimen may then be stained andcovered with a cover material. The cover material may then be coupled tothe carrier strip backing to form a carrier strip having a plurality ofanatomical pathology specimens disposed.

Yet other aspects of the invention relate to methods of facilitatingdiagnostic studies of anatomical pathology specimens. Such methodsinclude imaging an anatomical pathology specimen and storing a digitalimage of the specimen in a memory. A digital copy of the digital imageof the specimen may be distributed to a pathologist. A diagnosis may bereceived from the pathologist based on the digital image of thespecimen.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an elevation view of a specimen carrier strip.

FIG. 2 is a partial perspective view of a sample carrier strip.

FIG. 3 is a schematic view of a sample evaluation system.

FIG. 4 is a perspective view of a multi head staining subsystem.

FIG. 5 is a perspective view of a covering subsystem.

FIG. 6 is a schematic view of a computerized system for storing,distributing, and analyzing images of anatomical pathology specimens.

DETAILED DESCRIPTION

The following detailed description of the invention references theaccompanying drawing figures that illustrate specific embodiments inwhich the invention can be practiced. The embodiments are intended todescribe aspects of the invention in sufficient detail to enable thoseskilled in the art to practice the invention. Other embodiments can beutilized and changes can be made without departing from the scope of thepresent invention. The present invention is defined by the appendedclaims and the description is, therefore, not to be taken in a limitingsense and shall not limit the scope of equivalents to which such claimsare entitled.

Turning now to the drawing figures, and particularly to FIG. 1, aspecimen carrier strip 10 includes a backing 12 for supporting abiological specimen 14 shown as an infiltrated histology section. Insome embodiments, biological specimen 14 may be a surgical pathologyspecimen disposed within a specimen block portion 16 that may be made ofparaffin or other suitable material. A unique machine readableidentifier 18 may be provided for each biological specimen 14. Themachine readable identifier may be a one or two dimensional barcode, orany other machine readable identifier. In addition to the machinereadable identifier 18, an alphanumeric identifier 20 may also beprovided so a human technician can manually verify the identity of abiological specimen. While shown as a strip running laterally acrossstrip 10, the identifiers may be placed longitudinally along a side.When more than one identifier is used, they may be positioned next toone another, as shown, or placed in different areas.

Strip 10 is segregated into multiple specimen regions 24 by intermediateregions 22. Intermediate regions 22 may comprise a seam or region ofthinned carrier material (as shown in FIG. 2) to allow for bending ofstrip 10 at intermediate regions 22. Each specimen region 24 providesspace for both biological specimen 14 and a specimen identifier (i.e.machine readable identifier 18 or alphanumeric identifier 20). Sideregions 26 are along either longitudinal edge of strip 10. One or bothof side regions 26 may be provided with apertures, slots, notches,dimples, or other features to facilitate proper indexing of strip 10 inrelation to a piece of machinery. In other embodiments, an indexingfeature may be positioned in intermediate regions 22. A cover materialmay be attached to backing 12. The cover may be adhered, fused, orotherwise coupled to backing 12 at regions 22 and 26 to enclose andcover biological specimen 14.

Referring to FIG. 2, a specimen carrier strip 10 includes a backing 12for supporting biological specimen 14 that is contained in a specimenblock portion 16. Intermediate region 22 is shown as being a thinnedregion 28 of backing 12. Backing 12 may have an adhesive or other meansfor coupling block portion 16 to region 24. In general, an anatomicalpathology technician would prepare the specimen block 16 and place it inregion 24 of strip 10. A machine could then scan the machine readableidentifier 18, or the technician could manually enter an identifier intoa computer database. This identifier could be used to identify thespecimen and tie it to a specific patient through an electronic healthrecord or laboratory information system.

Referring to FIG. 3, a specimen evaluation system 100 may include aspecimen staining subsystem 30, a covering subsystem 32, an imagingsubsystem 34 and a storage subsystem 36. Strip 10 is fed to stainingsubsystem 30 where a staining device 38 is used to apply a stain toindividual biological specimens 14. The system may be configured toallow for different stains to be applied to adjacent biologicalspecimens 14 on strip 10. Strip 10 may be fed to specimen evaluationsystem 100 by any of a variety of passive or driven conveyors orcombinations of such conveyors. When a biological specimen 14 ispositioned under staining device 38, staining device 38 may be loweredto prevent the migration of stain to other specimens. When stainingdevice is in place, one or more of a variety of staining compounds maybe applied, including biological stains such as antibodies or chemicalstains including dyes and pigments. After the stain has been applied,staining device 38 may be raised to allow strip 10 to be indexed forwardand position a new biological specimen 14 under staining device 38. Inalternative embodiments, a variety of emersion baths containing solvatedstains may be provided. The position of the baths relative to strip 10may be changed such that one area 24 is positioned above a bath and maythen be submerged to apply stain to biological specimen 14. Strip 10 maybe passed through a mild heating zone or maintained at room temperatureto facilitate drying of any stain solvent that may be present.

After stain has been applied to the biological specimens, strip 10 maybe advanced to a covering subsystem 32. Cover subsystem 32 may include aroller 40, cover material spool 42, and a guide roller 44. Covermaterial 46 may be wound on spool 42 and fed over guide roller 44.Roller 40 may draw cover material 46 and laminate or otherwise couplecover material 46 to base 12 along continuous strip 10. As strip 10 isdrawn past roller 40, each region 24 includes a biological specimendisposed within a specimen block portion 16 and positioned betweenbacking 12 and cover 48.

After covering, strip 10 is advanced to imaging subsystem 34. In a basicform, imaging subsystem 34 includes a light source 50 and a highresolution imaging device 52. Light source 50 is shown below backing 12with imaging device 52 positioned above cover 48. Alternatively, thesepositions could be reversed. To allow light transmission through strip10 and to imaging device 52, backing material 12 and cover 48 aresufficiently transparent to allow for high resolution imaging ofbiological specimen 14. Many conventional materials may be usedincluding polyesters (such as polyethylene terephthalate, i.e. MYLAR),polyacrylates, epoxys, polyolefins, and other polymer materials that aresufficiently transparent while allowing for a construction of backing 12that can support specimen block portion 16 and flex in region 22. Inother embodiments, backing 12 may comprise more than one material. Insuch embodiments a transparent, rigid material may be used in region 23,while a more flexible material may be used in region 22. Suchembodiments may lack thinned region 28.

A variety of lighting sources may be used depending on the diagnostictesting being done. For example, if a fluorescent stain is used, thelight source may be selected to have a higher emission at or near theexcitation frequency for the stain. When an image is captured, it willgenerally include substantially all of region 24 such that thebiological specimen and the identifier (i.e. machine readable identifier18 and/or alphanumeric identifier 20) are captured together. Thecaptured image may be a digital image which may be stored in an imagedatabase or other memory. In some embodiments, it may be advantageous tohave multiple images taken of the same biological specimen with the sameor multiple imaging devices.

After imaging, strip 20 may be fed to a storage subsystem 36. Storagesystem 56 comprises a storage spool 54. As strip 10 is fed to storagespool 54, strip 10 flexes in regions 22 to wrap around spool 54. Whenspool 54 has reached its capacity it may be placed in a specimen librarythat would provide for high density storage of the specimens. Each spoolmay be identified with an identifier 56 which could, in turn, beassociated with all the specimens on storage spool 54. Alternatively,segments of strip 10 may be cut and the strips stacked and boxed forstorage. This would provide another option for high density storage ofspecimens.

Conventional glass microscope slides are typically used for specimenexamination and storage. Such slides are typically three inches long andone inch wide. With the use of strip 10, each biological specimen wouldonly require an area one inch long by one inch wide because additionalarea on ether side of biological specimen 14 would not be necessary forhandling. Also, conventional slides are made of glass or quartz whichcan be very brittle and easily broken. With the use of strip 10, othermore resilient materials may be utilized.

Referring to FIG. 4, a multi head staining subsystem is provided. In theembodiment shown, the staining device may include three heads 38 a, 38b, and 38 c extending from a base 58. Base 58 may be rotated to alignone of the three heads 38 over a biological specimen 14 on strip 10.When the appropriate head 38 is aligned over a biological specimen 14,base 58 and heads 38 may be lowered so that biological specimen 14 issubstantially covered by one of heads 38. A stain may then be applied tothe individual biological specimen. After application of the stain, base58 and heads 38 may be raised away from strip 10. In some embodiments,base 58 and heads 38 may be moved laterally away from strip 10 such thatrotation of base 58 is done away from strip 10. In this way, nobiological specimen would ever pass under more than one of heads 38thereby preventing unwanted stain migration.

Referring to FIG. 5, a covering subsystem may include a roller 40 and aguide roller 44. Guide roller 44 maintains the angel at which covermaterial 46 is supplied to roller 40 while the diameter of spool 42(shown in FIG. 3) reduces. Roller 40 is driven at the same rate at whichstrip 10 is advanced. Roller 40 includes edges 60 and 62 that contactregions 24 of strip 10 and cross portions 64 that contact each region 22as strip 10 advances. Edges 60 and 62, and cross portions 64 may beprovided to couple cover material 45 to strip 10 in one or more of avariety of ways including pressure fusing, partial melting, ultrasonicwelding, adhesive lamination, or any other suitable method.

Referring to FIG. 6, a computerized system for storing, distributing,and analyzing images of anatomical pathology specimens 200 is provided.The system includes a subsystem 210 which is utilized to route imagesand electronic health record information through system 200. Subsystem210 could be a subsystem operated by a healthcare provider with ananatomical pathology lab, or it could be operated by a third party.Subsystem 220 is utilized to link image data from image database 222 toan electronic health record database 224. Subsystem 220 may be alaboratory information system, and electronic health record system or acombination of both. Subsystem 210 may be used to route images to remotelocations 226, 228, and 230 where the images may be examined by apathologist without the need to evaluate the actual anatomicalspecimens. A report form may be provided with the images to thepathologist. Alternatively, the pathologist may be able to view imagesand fill in reports using a web based application. When the pathologisthas completed a pathology report, subsystem 210 can provide thatinformation to an electronic health record system for inclusion in thepatient's electronic health record.

In some embodiments, subsystem 210 may include additional functionalityto permit the evaluation of the various pathologists who may performdiagnostic studies based on images provided through a credibility test.In such embodiments, a credibility score may be assigned to one or moreof the various pathologists according to one of a variety of knowncredibility testing techniques. One such embodiment includes thedistribution of the same images to several pathologists and determininga consensus diagnosis. Variations from the consensus would be trackedand pathologists who most frequently vary from consensus diagnoses couldbe deselected for referral of future pathology studies. Additionally,subsystem 210 could be used to determine if a pathological diagnosisprovided varies from a subsequent diagnosis provided in the patient'selectronic health record. In some embodiments the credibility scorecould be calculated as the percentage of diagnostic studies performed bya particular pathologist in which that pathologist's diagnosis agreedwith the consensus diagnosis.

Although a few exemplary embodiments of the present invention have beenshown and described, the present invention is not limited to thedescribed exemplary embodiments. Instead, it would be appreciated bythose skilled in the art that changes may be made to these exemplaryembodiments without departing from the principles and spirit of theinvention, the scope of which is defined by the claims and theirequivalents.

The terminology used in the description of the invention herein is forthe purpose of describing particular embodiments only and is notintended to be limiting of the invention. As used in the description ofthe embodiments of the invention and the appended claims, the singularforms “a”, “an” and “the” are intended to include the plural forms aswell, unless the context clearly indicates otherwise.

Unless otherwise defined, all technical and scientific terms used hereinhave the same meaning as commonly understood by one of ordinary skill inthe art to which this invention belongs. All publications, patentapplications, patents, and other references mentioned herein areincorporated by reference in their entirety.

It will be further understood that the terms “comprises” and/or“comprising,” when used in this specification, specify the presence ofstated features, integers, steps, operations, elements, and/orcomponents, but do not preclude the presence or addition of one or moreother features, integers, steps, operations, elements, components,and/or groups thereof. It will be understood that relative terms areintended to encompass different orientations of the device in additionto the orientation depicted in the Figures.

Moreover, it will be understood that although the terms first and secondare used herein to describe various features, elements, regions, layersand/or sections, these features, elements, regions, layers and/orsections should not be limited by these terms. These terms are only usedto distinguish one feature, element, region, layer or section fromanother feature, element, region, layer or section. Thus, a firstfeature, element, region, layer or section discussed below could betermed a second feature, element, region, layer or section, andsimilarly, a second without departing from the teachings of the presentinvention.

It will also be understood that when an element is referred to as being“connected” or “coupled” to another element, it can be directlyconnected or coupled to the other element or intervening elements may bepresent. In contrast, when an element is referred to as being “directlyconnected” or “directly coupled” to another element, there are nointervening elements present. Further, as used herein the term“plurality” refers to at least two elements. Additionally, like numbersrefer to like elements throughout.

Thus, there has been shown and described several embodiments of a novelinvention. As is evident from the foregoing description, certain aspectsof the present invention are not limited by the particular details ofthe examples illustrated herein, and it is therefore contemplated thatother modifications and applications, or equivalents thereof, will occurto those skilled in the art. The terms “having” and “including” andsimilar terms as used in the foregoing specification are used in thesense of “optional” or “may include” and not as “required”. Manychanges, modifications, variations and other uses and applications ofthe present construction will, however, become apparent to those skilledin the art after considering the specification and the accompanyingdrawings. All such changes, modifications, variations and other uses andapplications which do not depart from the spirit and scope of theinvention are deemed to be covered by the invention which is limitedonly by the claims which follow. The scope of the disclosure is notintended to be limited to the embodiments shown herein, but is to beaccorded the full scope consistent with the claims, wherein reference toan element in the singular is not intended to mean “one and only one”unless specifically so stated, but rather “one or more.” All structuraland functional equivalents to the elements of the various embodimentsdescribed throughout this disclosure that are known or later come to beknown to those of ordinary skill in the art are expressly incorporatedherein by reference and are intended to be encompassed by the claims.

What is claimed is:
 1. A method of handling anatomical pathologyspecimens comprising: positioning a specimen carrier strip to receive aspecimen block portion including a specimen, the specimen comprising aninfiltrated histology specimen, the specimen carrier strip comprisingmultiple specimen regions segregated by intermediate regions, respectivespecimen regions comprising a specimen carrier strip backing forreceiving the specimen, respective intermediate regions comprising aregion of thinned carrier material configured to allow for bending ofthe specimen carrier strip at the respective intermediate regions;placing the specimen block portion on the specimen carrier stripbacking, the specimen block portion comprising a paraffin material, thecarrier strip backing comprising a transparent material to allow forhigh resolution imaging of the specimen; positioning a specimen carrierstrip backing of the specimen carrier strip under a staining device, thespecimen carrier strip having a specimen block portion disposed thereon,the specimen carrier strip including a specimen, positioning thestaining device such that the staining device is proximate to thespecimen, the staining device comprising a plurality of heads extendingfrom a base, the plurality of heads configured to rotate about the base,each head of the plurality of heads configured to dispense a stain;applying a stain to the specimen disposed within the specimen blockportion; raising the staining device such that the staining device isdistal to the stained specimen disposed within the specimen blockportion; transitioning the staining device laterally with respect to thestained specimen; rotating the base of the staining device while thestaining device is laterally transitioned with respect to the stainedspecimen; obtaining a digital image of the stained specimen via animaging subsystem, the imaging subsystem comprising an imaging devicefor capturing an image of the stained specimen and a light sourceconfigured to emit light having an emission characteristic at or near anexcitation frequency of the stain; storing the digital image of thefirst stained specimen as a data structure in an electronic healthrecord database; electronically distributing, via a computerizedsubsystem, the digital image of the first stained specimen to aplurality of pathologists to perform a diagnostic study of the firststained specimen; receiving a plurality of electronic reports fromrespective pathologists of the plurality of pathologists, the electronicreport comprising an evaluation of the respective pathologistcorresponding to the first stained specimen; calculating, via thecomputerized subsystem, a consensus diagnosis corresponding to the firststained specimen based upon the plurality of electronic reports;deselecting, via the computerized subsystem, a pathologist of theplurality of pathologists based upon a diagnostic study variance of thepathologist with respect to a consensus diagnosis of the plurality ofpathologists, wherein deselecting of the first pathologists comprisescausing the first pathologist to be deselected for referral of futurepathology studies.
 2. The method of claim 1, wherein the specimen is aninfiltrated histology section.
 3. The method of claim 1, furthercomprising performing a credibility test whereby pathologists may berated relative to one another on the of the accuracy of their respectivediagnostic studies.
 4. A method of facilitating diagnostic studies ofanatomical pathology specimens comprising: placing an anatomicalpathology specimen on a first specimen carrier strip backing;positioning the first specimen carrier strip backing under a stainingdevice; positioning the staining device such that the staining device isproximate to the specimen disposed within the first specimen carrierstrip backing, the staining device comprising a plurality of headsextending from a base, the plurality of heads configured to rotate aboutthe base to align with a respective specimen, each head of the pluralityof heads configured to dispense a stain; applying a stain to theanatomical pathology specimen disposed upon the first specimen carrierstrip backing; imaging, via an imaging subsystem, the stained anatomicalpathology specimen disposed upon the first specimen carrier stripbacking; storing a digital image of the stained anatomical pathologyspecimen in at least one of a database or a memory; distributing, via acomputerized subsystem, a digital copy of the digital image of thestained anatomical pathology specimen to a plurality of pathologists;receiving, via the computerized subsystem, a pathological diagnosis fromat least one of the plurality of pathologists based on the digital imageof the stained anatomical pathology specimen; determining, via thecomputerized subsystem, a consensus diagnosis based upon thepathological diagnosis; and deselecting, via the computerized subsystem,a first pathologist from the plurality of pathologists based upon adiagnostic study variance of the first pathologist with respect to theconsensus diagnosis, wherein deselecting of the first pathologistscomprises causing the first pathologist to be deselected for referral offuture pathology studies.
 5. The method of claim 4, further comprising:determining the credibility of at least one of the pathologists relativeto at least one other of the plurality of pathologists through thedetermination of credibility scores.
 6. The method of claim 5, furthercomprising distributing copies of the digital image, via a computerizedsubsystem, to at least one pathologist of the plurality of pathologistsbased upon a credibility score of the at least one pathologist, whereinthe digital image is distributed after determination of the credibilityscore.
 7. The method of claim 6, wherein the credibility score of the atleast one pathologist is calculated based on a percentage of diagnosticstudies in which the diagnosis of the at least one pathologist agreedwith a consensus diagnosis reached by those of the plurality ofpathologists.